MAY 2023LIFE SCIENCES REVIEW9ensuring equitable access as well as quicker access for patients without having to wait for the outcome of reimbursement negotiations· Pursue regulatory and reimbursement approvals across countries regardless of their healthcare budgets and pricing structuresHealth systems can:· Collaborate together to streamline their evidence requirements and approval processes for new treatments, both in terms of regulatory and reimbursement approvals. In order for cross-country collaborations to be successful, health authorities will need to align their requirements so that the methodologies and evidence submitted in joint submissions can be applied across all the member countries, without the need to duplicate efforts or submit additional evidence· Be more flexible in their evidence requirements and take on greater uncertainty for innovative treatments with immature data that have the potential to improve health outcomes for patients so they can be made available sooner· Be more open to accepting new pricing and payment models that accelerate patient access whilst managing uncertainty to payers and rewarding innovation for the pharmaceutical industryCan a Change in Legislation Help Bridge the Health Equity Gap in Europe?It is clear that the current market access environment is no longer sustainable. At the end of March 2023, the European Commission is expected to publish its long-awaited review of General Pharmaceutical Legislation (GPL). One of the key political drivers of this legislative review is a desire to speed patient access to medicines approved centrally by the European Medicines Agency. The Commission is expected to introduce the concept of `launch conditionality' whereby a medicine must be available in all 27 EU Member States within 2 years of receiving marketing authorisation. Medicines that fail this access hurdle will lose 1 year of regulatory data protection compared to the current situation. However, given the complexity and interdependencies of concluding price and reimbursement negotiations across a range of such diverse healthcare systems, this is a massive hurdle and will require significant commitment and change in practice by all stakeholders. A Change in Mindset is Needed The pharmaceutical industry has become disproportionally reliant on revenue from a small number of wealthy countries to sustain its business model. While this model may have been successful at fuelling innovation, it has come at a cost, in terms of global patient access and is resulting in ever greater variations in health outcomes. Pharmaceutical companies need to rebalance their mindset and develop a new, more inclusive, business model that allows for far more patients to benefit. At BeiGene, equitable access to innovative medicines is at the core of our company mission. We believe that all patients deserve access to high-quality and impactful medicines regardless of where they live in the world or their socio-economic status. In just 3 years, our Bruton tyrosine kinase inhibitor has been approved in over 60 countries worldwide and achieved access in 15 countries in Europe within 1 year of marketing authorisation.It is BeiGene's aspiration to be a global leader in the discovery, development, manufacturing, and commercialisation of innovative, affordable, and widely accessible medicines for any patient that needs them. Both pharmaceutical companies and health authorities can each play their part to bring medicines to patients quickly and affordably, and work together and with other stakeholders to identify the root causes of inequitable access and develop solutions that are sustainable and scalableSilvy Mardiguian
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